Description:

CALGB: 49903 ADVERSE EVENT FORM NCT00053339 Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2363-5625-477E-E034-0003BA0B1A09

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2363-5625-477E-E034-0003BA0B1A09

Keywords:

Clinical Trial

Adverse event

Breast Neoplasms

12/18/14 12/18/14 - Martin Dugas
6/3/15 6/3/15 -

Uploaded on:

June 3, 2015

DOI:

To request one please log in.

License :

Creative Commons BY-NC 3.0 Legacy

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

CALGB: 49903 ADVERSE EVENT FORM NCT00053339

Details

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 forms

StudyEvent: CALGB: 49903 ADVERSE EVENT FORM
1. INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

CALGB clinical trial administrative data

CALGB Form

CALGB Study No

CALGB Patient ID

From

To (M)

Amended data?

Yes (Yes)

Patient demographics

Patient's Name

Participating Group

Patient Hospital Number

Participating Group Protocol No.

Main Member Institution/Adjunct

Participating Group Patient No.

ADR Report

Was an ADR Report filed based on an event reported below?

No (No)

Yes (Yes)

Expected Adverse Events

IMT Code

CTC Adverse Event Term

CTC Grade (Coding Instructions: Use the most current version of the NCI Common Toxicity Criteria CTC to determine the grade for each event with the exception of Hand-foot syndrome see protocol section 12.8. If no adverse event is reported for a specific category, code grade = 0. DO NOT USE THE CALGB EXPANDED COMMON TOXICITY CRITERIA.)

Attribution (Attribution Codes)

Unrelated (unrelated to treatment)

Unlikely (unlikely to be related to treatment)

Possibly (possible related to treatment)

Probably (probably related to treatment)

Definitely (definitely related to treatment)

Person Completing Form

Completed By (Print or Type Name)

Date Completed

Ccrr Module For Calgb: 49903 Adverse Event Form

Back to the top of the page

Similar models

Show recommended models